Capsule: SOP for Processing Overages in Capsule Formulations – V 2.0

Auditor

2 days ago

Standard Operating Procedure for Processing Overages in Capsule Formulations

Department	Capsule Manufacturing
SOP No.	SOP/CM/110/2025
Supersedes	SOP/CM/110/2022
Page No.	Page 1 of 6
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to define the procedure for processing overages in capsule formulations. Overages are typically added to compensate for losses during the manufacturing process, ensuring that each capsule contains the required amount of active pharmaceutical ingredient (API). This SOP ensures that overages are processed accurately, safely, and in compliance with GMP standards.

2. Scope

This SOP applies to all formulations in capsule manufacturing that involve the addition of overages, including both hard and soft gelatin capsules. It covers the calculation, preparation, and processing of overages during the capsule filling process.

3. Responsibilities

Production Operators: Responsible for accurately preparing and processing the overage according to the specified formulation. They must ensure that the correct overage amount is added during production.
Quality Control (QC) Team: Responsible for verifying the overage content, ensuring that it complies with the required specifications, and performing checks on the final product.
Quality Assurance (QA) Team: Ensures compliance with SOP, verifies documentation, and reviews any deviations or discrepancies related to overage processing.
Production Supervisor: Oversees the entire process, ensures correct procedures are followed, and coordinates between production, QC, and QA teams.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the overage process is executed as per this SOP and in compliance with regulatory standards. The QA Manager is responsible for reviewing and approving the overage processing procedure, ensuring that the final product meets the required specifications.

5. Procedure

5.1 Calculating the Overage

Overages are typically calculated based on the estimated loss during manufacturing and the required API dosage per capsule. The following steps must be followed:

Determine the Required Overage Percentage
1. Consult the product formulation sheet to determine the overage percentage required for the specific formulation.
2. Common overage percentages range from 2% to 5% but may vary depending on the formulation and manufacturing process.
Calculate the Total Amount of Active Ingredient
1. Calculate the total required API based on the number of capsules to be produced and the required dosage per capsule.
2. Apply the overage percentage to the total API required to determine the additional quantity to be added to the batch.
Calculate the Total Weight of Ingredients
1. Calculate the total weight of the formulation ingredients, including the active ingredient (API), excipients, and overage.
2. Ensure that the final batch weight accounts for the overage to prevent under-dosing.

5.2 Preparing the Overage

Once the overage amount is calculated, proceed with preparing the overage for inclusion in the capsule filling process:

Prepare API and Excipients
1. Weigh the required amount of API and excipients using a calibrated balance, ensuring accuracy within the required tolerance limits.
2. Prepare the ingredients as specified in the formulation sheet, mixing them in the correct proportions, including the calculated overage.
Record the Preparation
1. Document the weights of all ingredients, including the overage, in the Batch Record (Annexure-1). Ensure that any changes made during the preparation are also recorded.
2. Ensure that the preparation log includes the batch number, date, and names of personnel involved in preparing the overage.

5.3 Processing the Overage During Capsule Filling

During the capsule filling process, the overage is added to the capsule formulation to compensate for losses. The following steps should be followed:

Check Capsule-Filling Machine Settings
1. Ensure that the capsule filling machine is calibrated to accommodate the overage amount and that it can handle any increase in the total weight of the capsule contents.
2. Verify that the fill weight system is calibrated, ensuring that the added overage does not lead to excessive variation in capsule weight.
Add the Overage to the Capsule Filler
1. Ensure the overage is added to the capsule filling system as per the calculated amount. This may require adding the overage in small portions to ensure uniform distribution throughout the batch.
2. Record the addition of overage in the production log.
Monitor Capsule Weight
1. After adding the overage, perform weight checks on randomly selected capsules throughout the production run to ensure that the weight is within acceptable limits.
2. If any capsules fall outside the acceptable weight range, investigate and correct the filling process.

5.4 Quality Control and Final Checks

Quality control checks must be conducted to verify that the overage was correctly processed and that the final product meets specifications:

Capsule Weight Testing
1. Test a random sample of filled capsules to verify that the weight is within the specified range.
2. Ensure that the weight consistency is maintained across the entire batch, accounting for the overage.
Uniformity of Content Testing
1. Perform content uniformity testing to ensure that the amount of API in the capsules is consistent and within the required limits.
Final Product Inspection
1. Inspect the final batch for any visual defects, such as cracks, leaks, or incomplete seals. If any defects are found, initiate a corrective action as necessary.

5.5 Documentation and Reporting

Proper documentation of the overage processing procedure is essential for traceability and regulatory compliance:

Record All Data
1. Record all relevant data, including overage calculations, preparation logs, batch records, and QC testing results, in the appropriate production logs (Annexure-1, Annexure-2, etc.).
Report Deviations
1. Any deviation from the standard overage processing procedure must be documented in the Deviation Log (Annexure-3), with corrective actions noted and reviewed by the QA team.

6. Abbreviations

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
QC: Quality Control
QA: Quality Assurance
API: Active Pharmaceutical Ingredient

7. Documents

Batch Record (Annexure-1)
Capsule Weight and Fill Volume Log (Annexure-2)
Deviation Log (Annexure-3)
Maintenance Log (Annexure-4)

8. References

USP <1163> – Pharmaceutical Dosage Forms: Capsules
FDA Guidelines for Capsule Manufacturing
Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch ID	Gelatin Composition	API Quantity	Overage Percentage	Added Overage	Operator	Approval Status
Batch 001	Standard	500mg	5%	25mg	Jane Smith	Approved

Annexure-2: Capsule Weight and Fill Volume Log

Sample ID	Capsule Weight (mg)	Fill Volume (mL)	Pass/Fail	Operator
Sample 001	550	1.2	Pass	John Doe

Annexure-3: Deviation Log

Deviation ID	Batch ID	Description	Corrective Action	Operator	Approval Status
DEV-001	Batch 001	Overage addition error	Recalculated overage and adjusted dosage	Jane Smith	Approved

Annexure-4: Maintenance Log

Equipment ID	Maintenance Date	Maintenance Activity	Performed By	Next Maintenance Due
Filling Machine 001	02/02/2025	Recalibrated filling system to accommodate overage	John Doe	02/02/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version	New SOP Creation	QA Head
01/02/2025	2.0	Added detailed corrective actions for overage discrepancies	Improved documentation and accuracy	QA Head